A Device for Rapid, Painless, Bedside Muscle Evaluation of Children
- Conditions
- Duchenne Muscular Dystrophy
- Registration Number
- NCT02340923
- Lead Sponsor
- Skulpt, Inc.
- Brief Summary
The purpose of this protocol is to perform Electrical Impedance Myography (EIM) testing on healthy children and children with duchenne muscular dystrophy so as to develop a new, convenient tool for the office based assessment of children with a wide variety of neuromuscular conditions.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 327
-
- Age 0-18
-
- Male
-
- Genetic or histopathologic diagnosis of duchenne muscular dystrophy, or signs and symptoms of DMD and genetic or histopathologic diagnosis in a family member.
-
- Age over 18
-
- Female
-
- Presence of a superimposed neuromuscular or other medical condition that substantially impacts the individual's health or ability to cooperate.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Electrical Impedance Myography Measurements Baseline (all subjects) & 3 months, 6 months, 1 year for returning subjects only Up to 11 muscles will be measured using EIM technology. These muscles include: Right Lateral Deltoid, Right Biceps, Right Triceps, Right Wrist Flexors, Right Wrist Extensors, Right Vastus Lateralis, Right Tibialis Anterior, Right Gastrocnemius, Right Gluteus Medius, Right Biceps Femoris, and Right Thoracic Parapinal.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (5)
Boston Children's Hospital
🇺🇸Boston, Massachusetts, United States
St. Louis Children's Hospital
🇺🇸St. Louis, Missouri, United States
Cincinnati Children's Hospital
🇺🇸Cincinnati, Ohio, United States
Children's Hospital Colorado
🇺🇸Aurora, Colorado, United States
Skulpt, Inc.
🇺🇸Boston, Massachusetts, United States